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Volk iNview User Manual

Retinal camera
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USER'S MANUAL / INSTRUCTIONS FOR USE
Volk iNview
Retinal Camera

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Summary of Contents for Volk iNview

  • Page 1 USER’S MANUAL / INSTRUCTIONS FOR USE Volk iNview Retinal Camera...

  • Page 2: Product Description

    Apple iPhone or iPod Touch. The Volk iNview mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on select iOS devices; specifically, iPhone 5s and 6, or iPod Touch (6 Generation).

  • Page 3: Table Of Contents

    10. LABELING 11. CLEANING INSTRUCTIONS 12. TECHNICAL DESCRIPTION Supported Electronic Camera Devices 13. INTELLECTUAL PROPERTY INFORMATION Patents Trademark 14. DISPOSING OF THE VOLK INVIEW 15. DEVICE CLASS 16. CONTACT 17. WARRANTY Product Warranty 18. ORDERING INFORMATION IM-088 Rev: A Effective: 11/02/15...

  • Page 4: Package Contents

    Official Pelican Watertight and Dustproof Case – supplied with fitted foam interior Volk Precision Optical Lens Cleaner Model Number: VPOLC Volk Precision Optical Lens Cleaner consists of a highly absorbent, lint-free optical towellete moistened to an exact saturation level with a unique combination of oil removers and cleaning agents.

  • Page 5: Application Instructions

    Loading the application Personal iOS device Visit the App Store on your Apple device and download the application “Volk iNview.” Place your device into the Volk iNview indirect lens holder as pictured in Figure 1, below. Figure 1 Prepackaged iOS device Charge the device fully before use.

  • Page 6: Using The Application

    Using the application Instructions for First Use of the Application This section contains instructions for setting up the Volk iNview application for the first time. It is strongly recommended that this section is read entirely before using your new Volk iNview.

  • Page 7: Using Application With Patient Information Encryption

    Figure 3 Summary Check List Turn device to airplane mode Adjust Screen Brightness setting to maximum Disable Auto-Brightness Using Application with Patient Information Encryption On first startup of the application, you will be presented with the choice to use the application in either encrypted mode or unencrypted mode (Figure 4).
  • Page 8 Note – users who choose to operate the Volk iNview Retinal Imager in an encrypted-mode need to take care ensuring that the entered password is securely retained. If an encryption password is ever forgotten, the only recourse is to first delete the Volk iNview software application (and all the patient data contained within the application), and then reload the Volk iNview application.

  • Page 9: Summary Checklist For Encrypted Vs. Unencrypted Mode

    The camera calibration process aligns the smart device field-of-view (FOV) and the point of focus with the Primary Imaging Lens. Note – the Volk iNview software application will only operate if the smart device in which it is installed is used with / calibrated to a Volk-supplied iNview retinal imaging attachment.

  • Page 10: Undertaking An Image Session

    Undertaking an Image Session Note – the Volk iNview Retinal Imager requires that the patient’s pupil diameter be 5mm or greater. The larger the patient pupil size, the easier it is to properly align the Volk iNview device to the patient’s eye.
  • Page 11 Volk iNview Retinal Imager. The Primary Imaging Lens that is used within the Volk iNview Retinal Imager is a 25D lens and it has a working distance of approximately 50mm. The large end of the Lens Tube is fashioned like an indirect BIO lens with the intention that the user position and stabilize the device using the patient’s forehead as a...
  • Page 12 The most effective way of properly aligning the Volk iNview Retinal Imager is to use the lead hand (the one in contact with the patient’s forehead) to make all the required adjustments in space. The hand closer to the electronic camera device should be held reasonably stable as the positioning adjustments are being made with the lead hand.
  • Page 13 Figure 10 Note – the most effective way to align the Volk iNview Retinal Imager is to rely on the lead hand to make the necessary positioning adjustments. At the sweet spot of operation, the red reflex will quickly expand from a slit to fill the entire field- of-view (FOV) of the Primary Lens Element.
  • Page 14 Figure 11 During the entire time the Volk iNview Retinal Imager is being aligned with the eye, the video stream is being analyzed. When an aligned and focused retina is detected, retinal images are automatically acquired and saved by the Volk iNview software application. Acquisition is demonstrated through a ‘camera shutter click’...
  • Page 15 Patient Imaging New Patients The Volk iNview software application allows the user to attach the patient’s name, first and last name, or unique patient ID to the retinal images that are taken. When a new patient is to be imaged and archived using the Volk iNview Retinal Imager, the user selects New Patient from the Main Program Display.
  • Page 16 Two different methods are available to attach patient information to the images taken using the Volk iNview Retinal Imager. One method is to enter a unique patient ID for every new patient being imaged and managed. Alternately, patient images can be managed by entering the patient’s first and last name, and birth date.
  • Page 17 In addition to the auto-acquisition feature, the Volk iNview Retinal Imager always gives the user the option of capturing an image on command. The user can capture a retinal image by touching anywhere in the Image Display Section of the Main Program Display (Figure 12).
  • Page 18 Press to view image capture gallery. Figure 6 To delete one or more of the images, the user marks images by selecting the small circle positioned in the right-upper quadrant of the image and then selects Done. Alternately, a full screen display of any of the images can be commanded by simply selecting that image.

  • Page 19: Imaging Steps Summary

    Position the Volk iNview Retinal Image approximately 100mm from the patient’s eye. Center the red reflex on the display. Move the Volk iNview Retinal Imager towards the patient keeping the red reflex centered on the display. When the red reflex fills the Primary Imaging Lens FOV, stabilize the device as the auto- acquisition capability begins to acquire and save retinal images (indicated by momentary flash of the screen and/or audible snap).
  • Page 20 Figure 8 Transferring Data to a PC or Mac The Volk iNview application can also be used to transfer images with patient information to your PC or Mac using iTunes. Before You Start If it is not installed already, download iTunes to your PC by going to http://www.apple.com/itunes/download/.
  • Page 21 Figure 9 Select the “Apps” menu item on the left side of iTunes. Scroll down until the File Sharing section is visible. Select the Volk iNview app and the file iNviewDataExport.zip will appear under the Volk iNview Documents heading. Now select the Volk iNviewDataExport.zip document, and click on the Save to… button. This will open a dialog box that will allow you to navigate to the location of your choosing to save the data.

  • Page 22: Indications For Use

    No modifications to the Volk iNview hardware are permitted. The Volk iNview application cannot be used unless the device is within the Volk iNview camera system. The Volk iNview must be used in adherence to the daily maximum exposures listed in Eye Safety below. Eye Safety All versions of the Volk iNview retinal imager (iPod Touch, iPhone 5s, iPhone 6) have been tested against ISO 15004-2:2007€...

  • Page 23: Important Symbols

    Important Symbols Caution. Consult the instructions for use for important cautionary information. The user is advised of important operating and maintenance instructions. Consult the instructions for use. Indicates that important operating instructions are included in this User Manual. Failure to follow these instructions could place the patient or operator at risk.

  • Page 24: Error Messages

    Error messages The following table shows the error messages within the Volk iNview application. For error messages that concern the iOS device or operating system, consult the iPod Touch or iPhone user guide available on the Apple website. Description of error message and action to be Message present in application taken.

  • Page 25: Device Parts

    Device Parts Applies to: VINVIEW-TCH (Volk iNview for iPod Touch) VINVIEW-5S (Volk iNview for iPhone 5S) VINVIEW-6 (Volk iNview for iPhone 6) Figure 20 Description Indirect Lens Holder Indirect Lens Camera Sleep button (iPod Touch) Camera Sleep Button (iPhone) Camera charging port...

  • Page 26: Labeling

    Labeling Part and lot number information is located on the lower portion of the Lens Tube (Figure 21). This information is required to complete the Product Registration Card that is supplied with the Volk iNview Retinal Imager. Figure 10 IM-088 Rev: A Effective: 11/02/15...

  • Page 27: Cleaning Instructions

    The Primary Imaging Lens can be cleaned using Volk Precision Optical Cleaner or the Volk Optical LensPen. Note - further instructions and cleaning options can be found in the Volk Cleaning and Care guide on the Volk website. Methods A and B are applicable to the Volk iNview.

  • Page 28: Technical Description

    Technical description Supported Electronic Camera Devices iPod Touch (6th Gen) iPhone 5s iPhone 6 Patient Pupil Size 5mm diameter or greater Field of View 50° Illumination White light LED (provided by electronic camera device) Working Distance 50mm Diopter Correction -20D to +20D autofocus accommodation Operating Modes User selectable –...

  • Page 29: Intellectual Property Information

    Intellectual Property Information Patents The Volk iNview Retinal Imager is protected by international patents. Patents have been issued in Japan and China. Patents are pending in the US, India, and the EU. Trademark Volk iNview is a registered trademark of Volk Optical Inc.

  • Page 30: Contact

    Contact Information on the Volk iNview Retinal Camera can be found on the Volk website at www.volk.com. If you have any questions or require service contact us at volk@volk.com for service or call us at (+1) 800-345-8655. Feedback on the application is always appreciated and any suggested improvements can be made using the Feedback button shown in Figure 22.

  • Page 31: Warranty

    Purchaser. If the product fails to function due to defects in either materials or workmanship, Volk will, at its option, either repair or replace the product without charge, subject to the Warranty Limitations.
  • Page 32 This Warranty does not cover service required because of disassembly, unauthorized modifications or service, misuse, or abuse. SELLER MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED, OF THE PRODUCT SUPPLIED HEREUNDER, INCLUDING, WITHOUT LIMITATION, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND ALL SUCH WARRANTIES ARE HEREBY EXPRESSLY EXCLUDED.

  • Page 33: Ordering Information

    Keeler Limited Clewer Hill Road Windsor Berkshire SL4 4AA Tel: +44(0) 1753 857177 Members of the European Union should contact their authorized Volk Distributor for disposal of this unit. Certificate FM 71461 IM-088 Rev: A Effective: 11/02/15 Page 33 of 34...
  • Page 34 Volk Optical Inc. 7893 Enterprise Drive Mentor, Ohio 44060 Toll free within the United States: 1.800.345.8655 Phone: 440.942.6161 Fax: 440.942.2257 Email: volk@volk.com Website: www.volk.com IM-088 Revision: A Effective: November 2, 2015 IM-088 Rev: A Effective: 11/02/15 Page 34 of 34...

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